In gynecological practice, vaginitis is one of the major reasons for visits by patients to medical practitioners. Vaginitis caused by fungi, particularly by Candida Albicans, may affect 5-40% of the female population attending medical practices or clinics. Fungal infections of this nature are encouraged by any change in the normal vaginal flora, and such change may in turn be linked with such factors as variation in ovarian hormonal activity and individual broad spectrum antibiotic therapy. The diagnosis and treatment of such infections is largely based on clinical symptoms and the microscopic appearance of the vaginal discharge; the most common symptoms of vulvo-vaginitis, in particular, are intense itching an burning, accompanied by skin erosions and sometimes satellite pustules. Clinical suspicion may be confirmed by elaborate and time consuming culturing techniques.
In U.S. Pat. No. 4,874,695, which issued Oct. 17, 1989 to Pincus, a method for identification of fungal microorganisms characterized as "rapid" involved culturing the microorganisms for 2-3 days, preparing an inoculum from the culture, mixing the inoculum with a chromogenic substrate (or separately with more than one such substrate) for detecting the presence or absence of one or more of acetate esterase, leucylglycine aminopeptidase and glycylglycine aminopeptidase by formation of a colored product or a product convertible to a colored product, and incubating the inoculum/substrate mixture(s) for 2-6 hours, whereby the unknown microorganism is identified by comparing with the enzyme activity of known genera and species. Thus, the overall procedure takes 2-3 days plus 2-6 hours. The entire contents of U.S. Pat. No. 4,874,695, including the literature and patent references therein, are expressly incorporated herein by reference.
A method for detecting Candida yeasts, Saccharamyces cerevisiae, Torulopsis glabrata and Aspergillus niger, in which the microorganism in question is grown in a medium containing sources of nitrogen and carbon, and chloramphenicol and potassium tellurite (to inhibit the growth of gram-positive and gram-negative organisms), as well as a biological pH indicator which changes color as the medium becomes more acidic from metabolic activity of the microorganism, is disclosed in U.S. Pat. No. 4,140,580, which issued Feb. 20, 1979 to Gibson et al. The entire contents of this U.S. Patent are expressly incorporated herein by reference. In U.S. Pat. No. 4,140,580, it is stated that the entire test can be completed in 12-18 hours, compared with the then current 36-48 hours.
Other known methods are the so-called gold standard diagnosis which employs culturing in different media; and a method using monoclonal antibodies plus latex agglutination. In a well-established method, potassium hydroxide solution is applied to a smear sample on a glass slide, whereby all cells are destroyed except Candida hyphae and spores, a microscopic examination being carried out to identify the organism. This (KOH) method is, however, subjective and requires considerable laboratory skills.